Principal Process Development Engineer

Imperative Care•Campbell, CA

10d•Onsite

About The Position

Imperative Care is changing the way stroke is treated and is developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies developed at Imperative Care directly impact human lives. The focus is on the needs of the patient, and they come first in everything we do.

Requirements

Bachelor’s degree in engineering, or related discipline, and a minimum of 12+ years of related experience; or equivalent combination of education and experience.
Ability to perform/oversee complex computer modelling simulations to determine the effects of design, materials, and process on the functional and reliability performance of the final product.
SME Experience with pilot/production line set-up, validation and scale-up in a controlled environment.
Superior analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP.
Deep knowledge and experience in FDA Design Control procedures and DFSS/DFM tools.
Exceptional project management and communications skills (both written and verbal) including Agile scrum frameworks.
Exceptional critical thinking and complex problem-solving skills – able to intuitively identify problems, logically and empirically associate cause and effect, and under a variety of perspectives and constraints, prioritise and provide creative, effective, practical and strategical solutions.
Expert knowledge in application of Engineering Principles, DMAIC methodology and medical device industry best practices.
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards.
Expert knowledge of GMP, GDP procedures and requirements.
Ability to work independently, lead others and influence/mentor teams, including across functionally.
Ability to travel – as required.

Nice To Haves

Master’s degree; or PhD may be considered as part of related work experience.

Responsibilities

Plan, establish and lead implementation of process design initiatives and projects for developing products to define, characterize, optimize, and validate stable, robust, and capable processes for the commercialization of intra-vascular medical devices.
Advise teams, with broad scope of discretion, on projects that develop, improve and qualify internal equipment and processes and oversee the administration and qualification of processes at external suppliers and contract manufacturers.
Use deep knowledge and superior critical thinking skills to plan and execute DOEs and process characterization studies, leading the analysis, validation, interpretation, documentation and reporting of data.
Oversee all stages of process design, including definition, selection, characterization, optimization and (re)validation for new product launches and existing commercial products, acting as a subject matter expert (SME).
Lead collaborative efforts to research, define and develop and improve new and existing processes, establishing methods and techniques with company-wide impact, including creating process windows, manufacturing control limits and workmanship standards.
Spearhead innovation by individually or collaboratively identifying and selecting new process technologies, demonstrating expert-level professionalism.
Lead and oversee the development, documentation and qualification of new or existing equipment and fixturing, directing process tasks and potentially personnel.
Direct and mentor the design, execution, test, analysis and interpretation of results from DOEs, advising on best practices and processes and leading the application of DMAIC principles to make data-driven decisions, find root cause and solve complex problems.
Oversee equipment and process documentation architecture, ensuring adherence to best practices and collaborate with cross functional teams to develop manufacturing systems and architecture, facilitating efficient workflows, effectivity monitoring control plans and lot history records.
Lead cross-functional team members to design, characterize, optimize, document, and control all manufacturing processes by defining and measuring critical process parameters (CPP) that impact critical quality attributes (CQA) of the product, while teaching analytical techniques and applying engineering principles to understand the impact and interaction of materials and processes on process and product outputs.
Provide technical subject matter expertise in projects that define manufacturable product design specifications and visual standards and oversee management and partnership with external suppliers by executing due diligence assessments, setting specifications for critical quality and manufacturing attributes (CQA, CMA) for materials and components and collaborating on development projects and the qualification/validation of external processes.